AUSTEDO^® was studied in a diverse patient population^1,2

Studies included patients aged 21-81 years^2-8

Largest elderly population (≥65 years) of any TD clinical study in RIM-TD (n=78)

See consistent results in patients at increased risk for TD

Patients had a range of psychiatric and comorbid conditions²

Gastrointestinal disorders
Cardiovascular disorders
Metabolism/nutritional disorders, including diabetes

Lipid disorders
General liver disorders*

Patients were taking concomitant medications, including those metabolized by CYP3A4/5 and CYP2D6^1,2,9

Antidepressants
Antipsychotics (atypical and typical)

VIEW EFFICACY RESULTS
FROM THE STUDIES VIEW INFORMATION
ON POLYPHARMACY

TD, tardive dyskinesia.

*Patients with hepatic impairment were excluded from studies. Hepatic impairment is defined as a loss of core functions, such as drug clearance, in patients with cirrhosis (stage 4 fibrosis).^2,10,11

REFERENCES: 1. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. 2. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 3. AUSTEDO XR^® (deutetrabenazine) extended-release tablets and AUSTEDO^® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 4. Sajatovic M, Alexopoulos GS, Jen E, et al. Improvements over time with valbenazine in elderly adults (≥65 years) with tardive dyskinesia: post hoc analyses of 2 long-term studies. J Clin Psychiatry. 2025;86(2):24m15550. 5. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13:773999. 6. Sajatovic M, Gandhi P, Konings M, et al. Long-term safety and efficacy of deutetrabenazine in patients aged ≥65 years with tardive dyskinesia. Poster presented at: American Association for Geriatric Psychiatry; March 14-17, 2025; Phoenix, AZ. 7. Hauser RA, Barkay H, Fernandez HH, et al. Effects of long-term deutetrabenazine treatment in patients with tardive dyskinesia and underlying psychiatric or mood disorders. Poster presented at: Psych Congress; October 29-November 1, 2021; San Antonio, TX. 8. Nasrallah H, Chen M, Barkay H, Gordon MF, Finkbeiner S. Long-term efficacy and safety of deutetrabenazine in postmenopausal women with tardive dyskinesia. Poster presented at: American Psychiatric Association; May 21–25, 2022; New Orleans, LA. 9. PubChem Compound Database. National Center for Biotechnology Information. Accessed March 26, 2025. https://pubchem.ncbi.nlm.nih.gov 10. Ravenstijn P, Chetty M, Manchandani P, Elmeliegy M, Qosa H, Younis I. Design and conduct considerations for studies in patients with hepatic impairment. Clin Transl Sci. 2023;16(1):50-61. 11. Smith A, Baumgartner K, Bositis C. Cirrhosis: Diagnosis and Management. Am Fam Physician. 2019;100(12):759-770.

Important safety information

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR^® and AUSTEDO^® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.

Please see full Prescribing Information, including Boxed Warning.

AUSTEDO® was studied in a diverse patient population1,2

AUSTEDO^® was studied in a diverse patient population^1,2